BEUDAMED
    FDA Adverse Event Other Summary report: N

    KRYPTONITE BONE CEMENT

    MDR report key: 1631496 · Received March 12, 2010

    Report

    Report Number
    1226001-2010-00003
    Event Type
    Other
    Date Received
    March 12, 2010
    Date of Event
    December 5, 2009
    Report Date
    February 12, 2010
    Manufacturer
    DOCTOR'S RESEARCH GROUP, INC.
    Product Code
    GXP
    PMA / PMN Number
    K091382
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS NOT CLEAR WHAT MAY HAVE CONTRIBUTED TO THIS EVENT AND MAY HAVE BEEN A COMPLICATION OF SURGERY. THERE IS NO DATA TO SUGGEST THAT THE KRYPTONITE MATERIAL PLAYED A ROLE IN PRODUCING FLUID IN THE PLEURA. WE WILL CONTINUE TO MONITOR POST MARKETING DATA. NO DOCUMENTATION WITHIN THE DHR WAS FOUND THAT WOULD INDICATE A NONCONFORMANCE TO SPECIFICATIONS THAT COULD HAVE CONTRIBUTED TO THIS EVENT. A RETAINER SAMPLE FROM THE BATCH IN QUESTION WAS MIXED AND NO ISSUES WERE OBSERVED WITH MIXING OR HARDNESS. IF ADDITIONAL INFO BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    A PT UNDERWENT A CARDIAC PROCEDURE WHERE THE STERNUM WAS CLOSED USING STAINLESS STEEL WIRES. THE STERNAL CLOSURE WAS LATER REVISED DUE TO BROKEN STAINLESS STEEL WIRES ONE DAY POST-OP AS A RESULT OF THE PT COUGHING. THE STERNAL CLOSURE WAS REVISED AND KRYPTONITE MATERIAL WAS USED. KRYPTONITE MATERIAL WAS NOT UTILIZED IN THE ORIGINAL PROCEDURE. IT WAS REPORTED THAT A SECOND REVISION PROCEDURE WAS PERFORMED DUE TO THE OBSERVATION OF LIQUID IN THE RIGHT PLEURA ON X-RAY. THE ORIGIN OF THE FLUID WAS NOT KNOWN SINCE THE PLEURA WERE NOT OPENED IN THE ORIGINAL SURGERY. NO ISSUES WITH KRYPTONITE WERE NOTED. THE IDENTIFIED PRODUCT AND PRODUCT CODE IS DESIGNATED FOR EXPORT ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KRYPTONITE BONE CEMENT BONE CEMENT GXP DOCTOR'S RESEARCH GROUP, INC. KRYP-Z-03 08262009

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK